LEADER 03665nam 2200505 450 001 9910821073203321 005 20230814215405.0 010 $a0-309-45797-1 010 $a0-309-45795-5 035 $a(CKB)4340000000252744 035 $a(MiAaPQ)EBC5295066 035 $a(EXLCZ)994340000000252744 100 $a20180310h20182018 uy 0 101 0 $aeng 135 $aurcnu|||||||| 181 $2rdacontent 182 $2rdamedia 183 $2rdacarrier 200 04$aThe drug development paradigm in oncology $eproceedings of a workshop /$fAmanda Wagner Gee [and three others], rapporteurs 210 1$aWashington, District of Columbia :$cThe National Academies Press,$d2018. 210 4$dİ2018 215 $a1 online resource (122 pages) $cillustrations (some color) 311 $a0-309-45794-7 320 $aIncludes bibliographical references at the end of each chapters. 330 $a"Advances in cancer research have led to an improved understanding of the molecular mechanisms underpinning the development of cancer and how the immune system responds to cancer. This influx of research has led to an increasing number and variety of therapies in the drug development pipeline, including targeted therapies and associated biomarker tests that can select which patients are most likely to respond, and immunotherapies that harness the body's immune system to destroy cancer cells. Compared with standard chemotherapies, these new cancer therapies may demonstrate evidence of benefit and clearer distinctions between efficacy and toxicity at an earlier stage of development. However, there is a concern that the traditional processes for cancer drug development, evaluation, and regulatory approval could impede or delay the use of these promising cancer treatments in clinical practice. This has led to a number of efforts--by patient advocates, the pharmaceutical industry, and the Food and Drug Administration (FDA)--to accelerate the review of promising new cancer therapies, especially for cancers that currently lack effective treatments. However, generating the necessary data to confirm safety and efficacy during expedited drug development programs can present a unique set of challenges and opportunities. To explore this new landscape in cancer drug development, the National Academies of Sciences, Engineering, and Medicine developed a workshop held in December 2016. This workshop convened cancer researchers, patient advocates, and representatives from industry, academia, and government to discuss challenges with traditional approaches to drug development, opportunities to improve the efficiency of drug development, and strategies to enhance the information available about a cancer therapy throughout its life cycle in order to improve its use in clinical practice. This publication summarizes the presentations and discussions from the workshop"--$cPublisher's description. 606 $aClinical trials$zUnited States$vCongresses 606 $aDrug development$zUnited States$vCongresses 606 $aDevelopmental pharmacology$zUnited States 607 $aUnited States 607 $aUnited States$2fast 615 0$aClinical trials 615 0$aDrug development 615 0$aDevelopmental pharmacology 676 $a610.724 702 $aGee$b Amanda Wagner 712 02$aNational Cancer Policy Forum. 712 02$aBoard on Health Care Services. 712 02$aHealth and Medicine Division. 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910821073203321 996 $aThe drug development paradigm in oncology$94070269 997 $aUNINA